Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension

Baker Heart and Diabetes Institute

Status: Completed

Conditions: Hypertension

Treatments: Other: Sham control; Device: Renal Denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT02444442

002/15

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of catheter-based renal denervation in reducing blood pressure in patients with resistant hypertension compared to a sham procedure. Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be switched to a single pill triple combination treatment prior to the procedure.

A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35 patients in the sham control arm.

The duration of this study is 36 months.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• systolic office BP ≥140mmHg and ambulatory day time average ≥135mmHg despite concurrent treatment with ≥3 anti-hypertensive drugs

Exclusion criteria

• renal artery anatomy ineligible for treatment
• eGFR <15mL/min/1.73m2 (using MDRD calculation)
• myocardial infarction, unstable angina or cerebrovascular accident within 3 months of screening visit
• life expectancy of <12 months
• female participants of childbearing potential must have negative pregnancy test prior to treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups

Renal Denervation

Active Comparator group

Description:

participants randomised to undergo renal denervation

Treatment:

Device: Renal Denervation

Sham control

Sham Comparator group

Description:

participants randomised to undergo sham procedure

Treatment:

Other: Sham control